The findings of a recent systematic review illustrated that evidence on antibiotics for otitis media with effusion (OME) is uncertain in children (aged 6 months to 12 years); they may slightly benefit resolution up to three months, but the impact on hearing is unclear. Long-term effects and potential harms are uncertain, necessitating careful consideration in a condition with high spontaneous resolution. This study aimed to evaluate the outcomes, including both positive and negative effects of administering oral antibiotics in patients with the accumulation of fluid in the middle ear cavity.

For this investigation, the Cochrane ENT Information Specialist meticulously examined the CENTRAL, Cochrane ENT Register, Ovid MEDLINE, Ovid Embase, ClinicalTrials.gov, Web of Science, ICTRP, and additional sources for both published and unpublished studies up to 20 January 2023. The study encompassed randomized controlled trials and quasi‐randomized trials in children aged 6 months to 12 years suffering from unilateral or bilateral OME. The inclusion criteria comprised 19 studies (2581 participants) comparing oral antibiotics (including trimethoprim, macrolides, cephalosporins, and penicillins) with either a placebo or no treatment.

The Cochrane study employed standard methods, prioritizing primary outcomes such as hearing, otitis media-specific quality of life, and anaphylaxis. Secondary outcomes included OME persistence, adverse effects, language and cognitive development, psychosocial skills, generic health-linked quality of life, parental stress, vestibular function, listening skills, and episodes of acute otitis media. GRADE was used to assess evidence certainty.

 

Antibiotics vs. Placebo

(a) Hearing

This comparison incorporated data from 11 studies, but none covered all outcomes. Limited meta-analysis was possible. One study suggested antibiotics may improve normal hearing in children within two months compared to a placebo, but certainty was low (Peto odds ratio 9.59, 95% confidence interval [CI] 3.51 to 26.18; 20/49 vs. 0/37; 1 study, 86 participants, very low certainty).

(b) Disease-specific quality of life

No studies examined disease-specific quality of life.

(c) Presence/persistence of OME

Between 6-12 months, antibiotics slightly decreased persistent OME compared to placebo, but the evidence was highly uncertain (risk ratio [RR] 0.89, 95% CI 0.68 to 1.17; 48% vs. 54%; number needed to treat [NNT] 17; 2 studies, 324 participants, very low certainty).

(d) Adverse event

Specific data on anaphylaxis was lacking. Three studies (448 children) reported adverse events, but evidence was highly uncertain, indicating very low certainty.

 

Antibiotics vs No Treatment

Eight studies were incorporated, with limited possibilities for meta-analysis.

(a) Hearing

Regarding hearing, one study indicated that the use of antibiotics might not have resulted in a significant difference when compared to no treatment in the final hearing threshold at three months (mean difference -5.38 dB HL, 95% CI -9.12 to -1.64; 1 study, 73 participants; low-certainty evidence). The available data on the return to normal hearing at 10 days were deemed too brief for an accurate assessment.

(b) Disease-specific quality of life

No studies addressed disease-specific quality of life.

(c) Presence/persistence of OME

Concerning the presence/persistence of OME, antibiotics might have reduced the proportion of children experiencing persistent OME at three months compared to no treatment (RR 0.64, 95% CI 0.50 to 0.80; 6 studies, 542 participants; low-certainty evidence).

(d) Adverse events

No specific data on anaphylaxis was offered in the research reviewed. Two of the studies, involving 180 pediatrics, reported adverse events in enough detail to suggest that no anaphylactic reactions eventuated. However, the evidence is considered very uncertain and of low certainty.

The certainty of evidence regarding the use of antibiotics for OME ranges from low to very low. While the use of antibiotics may show a modest positive impact on the resolution of OME within the first three months compared to no treatment, the overall influence on hearing remains highly uncertain.

The long-term effects of antibiotics remain unclear, and only a limited number of studies addressed potential harms. It is emphasized that considering pivotal endpoints, such as potential long-term effects, is fundamental when evaluating the overall benefits and risks of antibiotic therapy, especially in ailments having a high likelihood of spontaneous resolution.